FDA.reportPublic FDA data

NDC 67046-2000-03 - Fluconazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-2000
Requested NDC
67046-2000-03
Package NDCs from labels
67046-2000-3, 67046-2000-03
Manufacturer
Coupler LLC | Glenmark Pharmaceuticals Inc
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluconazole - Coupler LLC | Glenmark Pharmaceuticals IncCoupler LLC | Glenmark Pharmaceuticals Inc2026-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-2000-3Fluconazole30 in 1 BLISTER PACKTABLET301

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: L11K75P92J
Lactation Flow Drops 2149LACTATION FLOW DROPSProfessional Complementary Health Formulas66a063c4-aa38-4c8e-b361-ee841165edeb2026-01-08WarningsExact identifier
unii: L11K75P92J
Nocturnal Enuresis Drops 2011NOCTURNAL ENURESIS DROPSProfessional Complementary Health Formulas9cd29086-c9eb-4db1-a219-2a8bae3663d82026-01-08WarningsExact identifier
unii: L11K75P92J
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: L11K75P92J
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: L11K75P92J
Myosotis Combination 9234MYOSOTIS COMBINATIONProfessional Complementary Health Formulas8cc292dc-b959-4d81-8277-03044992fccb2026-01-08WarningsExact identifier
unii: L11K75P92J
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: L11K75P92J
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: L11K75P92J
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: L11K75P92J
FluconazoleFLUCONAZOLEZhejiang Poly Pharm. Co., Ltd.2a3ba181-5baa-5942-e063-6294a90a82b22026-01-07Warnings, Adverse reactionsExact identifier
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEAvPAK551a5c8f-57eb-2643-12c6-7c700584b49f2026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthwind Health Company, LLCf76bf2f7-1752-7656-e053-6394a90a8d222026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA077253
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLENorthwind Health Company, LLCc924c51c-ed7e-7e72-e053-2995a90adcd32026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBluePoint Laboratories83bcb8fc-53f1-4d7b-b083-0905b52c6c7e2025-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA077253
ndc (product): 68001-252
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
spl id: 472a93c7-fd2a-f837-e063-6294a90aed1b
spl set id: 83bcb8fc-53f1-4d7b-b083-0905b52c6c7e
unii: 8VZV102JFY
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.